Description

Aminoglutethimide Impurity A CAS NO 83417-11-2 is a key reference standard and impurity used in the pharmaceutical development and quality control of Aminoglutethimide, an aromatase inhibitor. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by enabling accurate identification and quantification of related substances. It is an essential material for analytical laboratories, quality assurance departments, and research institutions involved in pharmaceutical manufacturing, regulatory compliance, and method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Aminoglutethimide Impurity A in drug substance and drug product testing.
• Analytical Method Development and Validation (HPLC/GC): Used to develop, optimize, and validate chromatographic methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to monitor impurity levels and ensure the API meets stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used as a marker to track impurity formation and degradation pathways in stability-indicating assays for drug shelf-life determination.
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research and Development (R&D): Utilized in synthetic chemistry research to study the formation, fate, and purge of this specific impurity during API process development.

Basic Information

Product Name	Aminoglutethimide Impurity A
CAS No.	83417-11-2
Molecular Formula	C13H16N2O2
Molecular Weight	232.28 g/mol
Synonyms	3-(4-Aminophenyl)-3-ethylpiperidine-2,6-dione; 3-Ethyl-3-(4-aminophenyl)piperidine-2,6-dione; Aminoglutethimide Related Compound A; 1-(4-Aminophenyl)-1-ethyl-2,6-piperidinedione; Aminoglutethimide EP Impurity A; Aminoglutethimide USP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Aminoglutethimide Impurity A is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.